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Novana All-in-One One Step Perineal

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This product has been discontinued

Active ingredient
Dimethicone .02 mL/1 mL
Other brand names
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
April 4, 2012
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone .02 mL/1 mL
Other brand names
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
April 4, 2012
Manufacturer
NOVANA MEDICAL LLC
Registration number
part356
NDC root
76077-500
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

It seems that the provided information does not include specific details about the drug's name, general description, or its mechanism of action. Therefore, I am unable to create a summary that addresses what the drug is or what it is used for. If you have more information or specific details about the drug, please share them, and I would be happy to help you craft a consumer-friendly summary.

Uses

You can use this product as needed to help keep your skin healthy. It's important to change wet or soiled undergarments promptly to prevent irritation. When applying the product, make sure to gently wipe the affected area with a clean, soft cloth. For best results, use it with each change of undergarments, especially at bedtime or whenever you might be in wet garments for an extended period.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this product.

Dosage and Administration

You should only use this medication on the outside of your body, as it is meant for external use only. Make sure to apply it as directed by your healthcare provider, and avoid using it on any areas that are not specified. Always follow the instructions provided to ensure safe and effective use. If you have any questions about how to use it, don’t hesitate to ask your doctor or pharmacist for guidance.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it is appropriate for your individual health needs. They can provide personalized advice and address any questions or concerns you may have.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid getting it in your eyes, as this can cause irritation. If your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, you should stop using the product and consult your doctor.

Additionally, do not apply it to deep or puncture wounds, animal bites, or serious burns, as these situations may require different medical attention.

Warnings and Precautions

This product is for external use only, so please avoid getting it in your eyes. If you notice that your condition worsens, or if your symptoms last longer than 7 days or improve only to return shortly after, stop using the product and consult your doctor. Additionally, do not apply it to deep or puncture wounds, animal bites, or serious burns.

If the product is swallowed, seek emergency medical help or contact a Poison Control Center immediately. Your safety is important, so please take these precautions seriously.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

There is currently no specific information available regarding the use of NOVANA ALL-IN-ONE ONE STEP PERINEAL - dimethicone lotion during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products, including this lotion, to ensure it is safe for you and your baby.

Lactation Use

Currently, there is no specific information available about the use of NOVANA ALL-IN-ONE ONE STEP PERINEAL dimethicone lotion for nursing mothers or its effects during lactation (the period of breastfeeding). This means that if you are breastfeeding, it’s important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize your health and your infant's well-being when considering any new products while nursing.

Pediatric Use

It's important to keep this medication and all other drugs out of the reach of children. If a child accidentally swallows this medication, you should seek medical help immediately or contact a Poison Control Center for assistance. Taking quick action can help ensure their safety. Always be vigilant about where medications are stored to prevent any accidental ingestion.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's great to know that there are no reported drug interactions or laboratory test interactions with this medication. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication is key to managing your health effectively.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep this product, as well as all medications, out of the reach of children to prevent accidental ingestion. If the product is swallowed, seek medical assistance or contact a Poison Control Center immediately for guidance. Taking these precautions will help you use the product safely and effectively.

Additional Information

The medication is administered topically, meaning it is applied directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any specific questions about how to use this medication or its effects, be sure to consult your healthcare provider for more information.

FAQ

How should I use this product?

Apply as needed to the affected area, change wet and soiled undergarments, and gently wipe with a clean, soft cloth. It's recommended to use it with each undergarment change, especially at bedtime or when exposure to wet garments may be prolonged.

Are there any warnings I should be aware of?

This product is for external use only. Avoid contact with eyes, and stop use and consult a doctor if the condition worsens or symptoms last more than 7 days.

What should I do if I accidentally swallow this product?

If swallowed, get medical help or contact a Poison Control Center immediately.

Can I use this product on deep wounds or serious burns?

No, do not use this product on deep or puncture wounds, animal bites, or serious burns.

Is this product safe to use during pregnancy or while nursing?

There is no specific information regarding the use of this product during pregnancy or while nursing.

How should I store this product?

Store at room temperature and keep it out of the reach of children.

Packaging Info

Below are the non-prescription pack sizes of Novana All-in-One One Step Perineal (dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Novana All-in-One One Step Perineal.
Details

Drug Information (PDF)

This file contains official product information for Novana All-in-One One Step Perineal, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Novana Medical 4oz All in One is presented in a 4-ounce container. The product is classified as an image/jpeg media type. Further details regarding its chemical composition, structural formula, or inactive ingredients are not provided.

Uses and Indications

This drug is indicated for the management of skin irritation associated with wet and soiled undergarments. It should be applied as needed to the affected area, ensuring that the area is gently wiped with a clean, soft cloth prior to application.

The drug is recommended for use with each undergarment change, particularly at bedtime or during any period when exposure to wet garments may be prolonged.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The product is intended for external use only. Healthcare professionals should ensure that the medication is applied exclusively to the affected area of the skin. Prior to application, the area should be cleaned and dried thoroughly.

The recommended dosage and frequency of administration will depend on the specific condition being treated. It is essential to follow the prescribed dosing regimen, which may vary based on individual patient needs and response to therapy.

Patients should be advised to apply the medication as directed, avoiding contact with eyes, mucous membranes, and open wounds. In the event of accidental contact, the area should be rinsed thoroughly with water.

Healthcare professionals should monitor patients for any adverse reactions and adjust the treatment plan as necessary.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only, this product must be applied with caution. Healthcare professionals should advise patients to avoid contact with the eyes during application. In the event of worsening conditions or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, patients are instructed to discontinue use and consult a physician.

This product is contraindicated for use on deep or puncture wounds, animal bites, or serious burns. It is essential to educate patients on these restrictions to prevent complications.

In cases of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare providers should remain vigilant and encourage patients to report any adverse reactions or concerns during the course of treatment.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes during application. In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional.

Additionally, this product should not be applied to deep or puncture wounds, animal bites, or serious burns. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Novana All-in-One One Step Perineal (dimethicone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Novana All-in-One One Step Perineal.
Details

Pediatric Use

Pediatric patients should be advised to keep this and all medications out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of NOVANA ALL-IN-ONE ONE STEP PERINEAL - dimethicone lotion during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the lack of data on potential fetal impacts. It is advisable to weigh the benefits against any unknown risks when considering the use of this product in pregnant patients.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for NOVANA ALL-IN-ONE ONE STEP PERINEAL dimethicone lotion. Therefore, the effects on breastfed infants and the excretion of the drug in breast milk remain undetermined. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this product to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event that the medication is swallowed, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature to maintain its efficacy.

Healthcare professionals are advised to ensure that this product, along with all medications, is kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Additional Clinical Information

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Novana All-in-One One Step Perineal, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Novana All-in-One One Step Perineal, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.